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Sr. Regulatory Document Formatting Specialist at Vaxcyte
San Carlos, United States
Job Descrption
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making. Summary:
This role in Regulatory Operations will format and finalize documents for regulatory submissions. Ideal candidates will have experience formatting complex documents, in-depth understanding of Microsoft Word and Adobe Acrobat Pro, and familiarity with using document templates. This role will assist with regulatory submission planning, preparation, and QC to ensure high quality, timely submission of regulatory filings to health authorities. This is a full-time, remote position.
Essential Functions:
- Using Word to format documents that include tables of contents, headers and footers, links, styles, figures, and multiple-page tables.
- Working in a collaborative authoring environment (Veeva RIM).
- Reviewing documents to ensure that formatting is consistent throughout documents in accordance with internal templates and style guide (use of abbreviations, in-text citations, hyperlinks, terminology, bibliographies, etc.).
- Maintaining the list of literature for regulatory submissions and obtaining copies of literature, as needed.
- Communicating effectively with the Regulatory team and other functional groups, as needed, to meet project timelines.
- Interacting with the external publisher to support publishing of regulatory submissions.
- Assisting with Regulatory Operations efforts to implement and improve systems, processes, and/or tools.
- Comprehensive knowledge of formatting and document assembly using MS Word including Track Changes and Comments functions and document styles.
- Proficient with Adobe Acrobat Pro, PowerPoint, and Excel.
- Excellent attention to detail and organizational/time-management skills.
- Must work well with others.
- Must be accountable, adaptable, and dependable.
Requirements:
- At least 2 years of experience in Regulatory Operations with formatting/ word processing documents for regulatory submissions.
- Accustomed to fast-paced, highly-regulated environment with the ability to work independently.
- Familiarity with Veeva RIM is a plus.
- Experience using document templates; familiarity with OmniTemplates a plus.
- Sound business ethics, including the protection of proprietary and confidential information, is required.
- College degree, AA/AS or BA/BS.
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